Intrauterine G-CSF Administration in RIF (G-CSF)

December 20, 2018 updated by: Gurgan Clinic

Intrauterine G-CSF Administration in Recurrent Implantation Failure

Aim of this study is to investigate the effects of intrauterine G-CSF on endometrial thickness, clinical pregnancy rate and live birth rate in a recurrent implantation failure (RIF) group

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was designed as a prospective randomized controlled trial with the involvement of 200 RIF group patients.The procedure will perform by administering 30 mIU of Leucostim®(Filgrastim [G-CSF] 30mIU/mL; DEM Medical, Dong-A; South Korea) through slow infusion into the endometrial cavity using a soft embryo transfer catheter. Normal saline of 1 mL will be infused into the endometrial cavity in the same way in the control group. The standard ICSI procedure will use for all patients, and fresh cycle embryos will be transferred on the third or fifth day.

Study Type

Interventional

Enrollment (Actual)

157

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Cankaya
      • Ankara, Cankaya, Turkey, 06640
        • Gurgan Clinic IVF and Women Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women under the age of 40 who met the RIF definition
  • Follicle-stimulating hormone (FSH) levels were <15 IU/mL

Exclusion Criteria:

  • Patients with congenital uterine anomalies
  • Patients with Asherman's syndrome
  • Patients with uterine cavity distorted by myoma or endometrial polyps
  • Patients with confirmed endometriosis or endometrioma
  • Patients for whom G-CSF was contraindicated (active infections, kidney disease, sickle cell anemia, malignancies, chronic neutropenia)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: G-CSF
Patients in the G-CSF group will receive G-CSF once a day on hCG day, before hCG injection. The procedure involved the administration of G-CSF through slow infusion into the endometrial cavity using a soft embryo transfer catheter.
Drug: G-CSF
Slow infusion of G-CSF into the endometrial cavity using a soft embryo transfer catheter.
Other Names:
  • Leucostim
Placebo Comparator: Control group
Normal saline of 1 mL was infused into the endometrial cavity in the same way in patients in the control group
Other: Saline
Slow infusion of saline into the endometrial cavity using a soft embryo transfer catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 1month
Gestational sac in USG per embryo transfer
1month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endometrial thickness
Time Frame: 1month
Measurement of endometrial thickness as millimeter
1month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gurgan Clinic

Investigators

  • Principal Investigator: Ziya Kalem, MD, Gurgan Clinic IVF and Women Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

December 20, 2018

Study Completion (Actual)

December 20, 2018

Study Registration Dates

First Submitted

December 19, 2018

First Submitted That Met QC Criteria

December 19, 2018

First Posted (Actual)

December 20, 2018

Study Record Updates

Last Update Posted (Actual)

December 24, 2018

Last Update Submitted That Met QC Criteria

December 20, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20182

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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